CEFIC / APIC: Auditing Guide Page 1/40ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE活性原料药委员会(APIC)Auditing Guide审计指南CEFIC / APIC: Auditing Guide Page 2/40Content1. Acknowledgements2. Introduction3. Glossary4. Scope5. Legal Requirements6. Auditing6.1 Audit Types6.1.1 General Considerations6.1.2 Audit Classifications6.1.2.1 Internal Audits6.1.2.2 External Audits6.1.3 Justification6.2 Organisational Aspects6.2.1 Company Policy6.2.2 The Internal Audit Programme6.2.3 Aspects Of External Audits6.2.4 Hosting Audits6.3 Steps In Managing The Audit6.3.1 Introduction6.3.2 Pre-Audit Information6.3.3 Preparation6.3.4 Performing The Audit6.3.5 Reporting The Audit And Auditee Response6.3.6 Follow Up Of Progress With Remedial Actions6.3.7 Possible Audit Breakdown6.4 Content Of An Audit6.5 Documentation6.5.1 Principle6.5.2 Types Of Documentation6.5.3 Recommendations For Compiling And Handling The Audit Report6.5.4 Classification Of Observations6.5.5 Archiving6.6 Qualification And Attributes Of Auditors6.6.1 Training, Experience, Education, Background6.6.1.1 Education6.6.1.2 Training6.6.1.3 Experience6.6.2 Mental Stability6.6.3 Conflict Situations, Compatibility6.6.4 Social Competence6.6.5 Communication Skills6.6.6 Flexibility6.6.7 Requirement For Lead Auditor6.6.8 Assessment Of Auditor Performance6.6.9 Certification For Auditors6.7 Future Development Of Auditing7. Benefits8. References9. AppendicesAppendix A: Secrecy AgreementAppendix B: Customer QuestionnaireAppendix C: Aide MemoireAppendix D: Audit Report (template)CEFIC / APIC: Auditing Guide Page 3/40目录1 致谢 2 介绍3 术语4 范围5 法律要求6 审计6.1. 审计类型6.1.1. 总则6.1.2. 审计的分类6.1.2.1. 内部审计6.1.2.2. 外部审计6.1.3. 审计原因6.2. 组织机构6.2.1. 企业方针6.2.2. 内部审计程序6.2.3. 外部审计机构6.2.4. 审计成员6.3. 审计管理步骤6.3.1. 介绍6.3.2. 预审信息6.3.4. 进行审计6.3.5. 审计报告以及审计反馈6.3.6. 整改措施及实施6.3.7. 审计中断6.4. 审计内容6.5. 审计文件6.5.1. 原则CEFIC / APIC: Auditing Guide Page 4/406.5.2. 文件类型6.5.3. 编写和处理审计报告的建议6.5.4. 检查资料的分类6.5.5. 文件归档6.6. 审计员的资格和6.6.1. 培训、经验、教育、背景6.6.1.1. 教育6.6.1.2. 培训6.6.1.3. 经验6.6.2. 心理稳定6.6.3. 冲突状况,协调6.6.4. 交际能力6.6.5. 沟通能力6.6.6. 适应性6.6.7. 审计组长的要求6.6.8. 审计院表现评定6.6.9. 审计员的资格证6.7. 审计活动的未来发展7. 利益8. 参考9. 附录附录A 协议的保密附录B 用户调查附录C 备忘录附录D 审计报告（模板）CEFIC / APIC: Auditing Guide Page 5/401. AcknowledgementsThis document was drawn up by a group of experts within CEFIC / APIC. We thank them for their work and efforts spent as well as for their kindly co-operation, intensive discussions and fruitful comments:Eva Lindqvist (AstraZeneca)Lothar Hartmann (Hoffmann-La Roche)Robert Hopkins (GlaxoWellcome)Henri Leblanc (Rhodia)Jörg Sachse (K + S Aktiengesellschaft)Giancarlo Scuderi (retired, former Bracco)Willy Verhaegen (Omnichem)Frank Zimmermann (retired, former Knoll AG)1. 致谢本文是由活性原料药委员会（CEFIC / APIC ）的专家组织撰写的. 对他们的辛勤工作以及紧密合作,精辟的讨论以及富有成效的评论深表感谢。
他们是：Eva Lindqvist (AstraZeneca)Lothar Hartmann (Hoffmann-La Roche)Robert Hopkins (GlaxoWellcome)Henri Leblanc (Rhodia)Jörg Sachse (K + S Aktiengesellschaft)Giancarlo Scuderi (retired, former Bracco)Willy Verhaegen (Omnichem)Frank Zimmermann (retired, former Knoll AG)2. IntroductionAudit tourism or audit terrorism?Neither is acceptable, but either may occur if an auditor is less than professional in his or her approach. All too often inadequate training and/or preparation of the auditor results in a lack of effectiveness, a miss of systematic approach and a demonstration of poor GMP knowledge by the auditors. A number of supplier driven audits have led to poor standards by incompetent auditors.CEFIC / APIC: Auditing Guide Page 6/40In contrast, an audit performed by a well trained and thoroughly prepared auditor can be highly beneficial by identifying areas for genuine improvement. Therefore an audit has not to be seen as interrogation with the auditee as permanent looser, it is a comparison of what is laid down to what is in place. It is management's responsibility to initiate the necessary actions: either adoption of procedures and standards or taking corrective actions.There is no document in existence providing sound scientific rationale for GMP auditing as they are common in other areas like finance or ISO. Auditing in the pharmaceutical area is a relatively new phenomenon. It is only within the last 10 years that internal and supplier audits have become important. In some companies these audits consume up to 30% of their working time.But the API manufacturers have to deal not only with an inflation of audits, but also with different kinds of audits, other than GMP that are subject to regulatory, safety, environmental and financial aspects. Auditees become stressed and the potential advantages of audits are often going to be lost.For the purpose of this guide it is appropriate to make a distinction between an “audit”and an “inspection”. The term “inspect。